Montana is now the only state in the country that licenses clinics to sell drugs the FDA has not approved. The implementing rules for its experimental treatment centers took effect July 25, 2026, and national coverage caught up this week — Politico and STAT both ran the story on September 16, followed by a Daily Montanan commentary on September 18 arguing the state should watch carefully who actually shows up to apply.
For anyone who buys peptides, that is an obvious question to ask: does this open a legal, physician-supervised route to compounds that currently only exist in the research channel? The answer turns on one clause of Montana law, and the clause is narrower than the headlines suggest. So we read the adopted rules, pulled the statutory definition, and ran every peptide the FDA's advisory committee endorsed in July against the ClinicalTrials.gov registry. The result is a short list.
Research-context information only. This article reports on state law, adopted administrative rules and publicly posted clinical trial registry records. It is not medical or legal advice, and nothing here is a recommendation to use, obtain or dose any compound. BPC-157, TB-500, KPV, MOTS-c, epitalon, semax and retatrutide are not approved by the FDA for human use. Material sold through the research channel is research-use-only, is not manufactured or labeled to investigational-product standard, and is a different thing from product supplied under institutional control inside a trial or a licensed facility. Possession or use of investigational drugs such as retatrutide outside an authorized clinical trial may be illegal in your jurisdiction. Consult a licensed physician for personal medical decisions.
What Montana actually did
Senate Bill 535 was signed by Governor Greg Gianforte in May 2025. It expanded the state's existing right-to-try framework in two structurally important ways: it removed the terminal-illness restriction, so every patient is eligible, and it created a licensure category — the experimental treatment center — where a facility can recommend and administer investigational products for compensation.
The rules that make that operational were adopted as NEW RULES 1 through 25, codified at ARM 37.106.3301 through 37.106.3325, with a final rulemaking action date of July 25, 2026. The Montana Administrative Register notice runs to 134 comment-and-response pairs, which is a useful document precisely because the state had to say out loud what it would and would not allow.
The operating requirements are not light. A center needs:
| Requirement | Standard as adopted |
|---|---|
| Medical director | Montana-licensed physician, three-year internal medicine residency, licensed in Montana at least one year |
| Review board | At least four members including a Montana-licensed physician, a researcher with clinical outcome data expertise, and an ethicist, with no conflicts of interest |
| Patient agreement | Written, itemizing treatment name, form, clinical trial phase, all anticipated costs and billing method |
| Patient file | History and physical within 12 months, plus documented proof that FDA-approved options were attempted |
| Adverse events | Reported to the department within five days |
| Licensing fees | Set by statute at 50-5-250(3)(a) and (b), MCA — the department declined to create a sliding scale |
| Profit obligation | Two percent of net annual profits directed toward experimental-treatment access for Montana residents |
None of that is the constraint that matters for peptides, though. The constraint is the definition.
The Phase 1 clause
Montana defines an experimental treatment at 50-12-102(1), MCA as "the provision of a medical intervention by a health care provider involving an investigational drug, biological product, device, or other treatment that has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the United States food and drug administration."
That sentence is the entire gate, and the rulemaking record shows the department defending it twice against attempts to widen it.
A commenter asked that centers be allowed to describe a product's "prior development history and regulatory status in lieu of a phase designation where a formal phase classification does not apply" — which is, in practice, a request to admit compounds that have human use behind them but no registered trial. The department declined, quoting the statute back and stating flatly that "a treatment or device must have undergone phase 1 clinical trials to be considered for administration at an ETC."
A second commenter asked the department to exclude dietary supplements and wellness products with "no credible on-ramp to the FDA approval pathway." The department declined that too, but for a revealing reason: such products are already excluded, because "treatments that have not successfully completed a phase 1 trial are already statutorily excluded from being administered by ETCs."
One narrow secondary door exists. The rules define a "qualified medical institution" as one that "has generated documented clinical evidence supporting the safety of a medical intervention equivalent to that required for successful completion of a phase I clinical trial" while operating under a regulatory authority recognized by international standards, or one demonstrating substantially equivalent standards for data quality, monitoring and patient protection. That clause contemplates foreign safety data. It still requires documented, regulator-supervised, Phase 1-equivalent evidence.
Running the six peptides against the registry
In July 2026, the FDA's Pharmacy Compounding Advisory Committee voted to support adding six peptides to the 503A bulks list — BPC-157, KPV, TB-500, MOTS-c, epitalon and semax — over the objections of FDA's own reviewers. That vote is the closest thing the category has to a federal endorsement, and it makes those six the natural test set for Montana's gate.
Here is what the ClinicalTrials.gov registry returned on an intervention-field search run September 19, 2026.
| Compound | Interventional records | Phase 1 successfully completed? |
|---|---|---|
| BPC-157 | 4 | No. NCT07803250 (University of Arkansas) is Phase 1, not yet recruiting, listed start January 2027. NCT02637284, a 2015 Phase 1, is listed status unknown with no posted results. NCT07437547 is a recruiting Phase 2. |
| TB-500 | 1 | No. NCT07487363 is Phase 1/2 and recruiting. |
| MOTS-c | 1 interventional drug record | No. NCT07505745 is Phase 2 and recruiting; no completed Phase 1 record. |
| KPV | 0 | No registered interventional record. |
| Epitalon / epithalon | 0 | No registered interventional record. |
| Semax | 0 | No registered interventional record. |
| Retatrutide (comparison) | 12 active | Yes. Multiple completed Phase 1 records, including first-in-human safety study NCT03841630. |
Zero of the six clear the gate on today's registry.
The nearest miss is instructive. TB-500 as sold in the research channel is the thymosin beta-4 fragment; the full-length parent molecule does have completed Phase 1a and Phase 1b healthy-volunteer studies (NCT04555824, NCT04555850) and completed Phase 2 and Phase 3 ophthalmic programs under the RGN-259 development name. Those are real records — for a different molecule than the one on a vendor's product page. We covered the same distinction in our TB-500 buying guide, and it is exactly the kind of gap a statutory phase requirement is designed to catch.
BPC-157 is the other near-miss, and it moved recently: a US academic medical center registered a randomized, placebo-controlled trial on September 3, 2026, which we covered in BPC-157 Human Trial: US University Tests Rotator Cuff. It is a Phase 1, it has not started, and its listed primary completion is August 2027. Registration is not completion. On a strict statutory read, the earliest BPC-157 could plausibly clear Montana's gate is late 2027 — and only if that trial runs, finishes and reports.
